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Completed

NCT Number: NCT03170167

Communitas: A Program for Teens Living With Chronic Illness and Their Families

The proposed pilot study is an evaluation of Communitas, a mind-body skills group visit and for 12-19 year-olds living with chronic physical illness. The goal of this study is to assess the efficacy and feasibility of these group visits. During 2017-2018, the investigators will recruit 50-100 patient and 50-100 parent enrollees of Communitas to participate in this study. The study will be a pre-post evaluation, without a control group, using validated patient-report assessments at baseline, after completion of the group visits, and 3 months later. The primary outcome variables will be physical and mental wellbeing, stress, mood, resilience, mindfulness, and social support. Paired t tests will be used to assess changes from baseline to immediately post-intervention & 3 months post-intervention. The investigators will also calculate Cohen's d effect sizes, to help them understand the degree to which an effect is present in the population.

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Key information

Conditions

Chronic Illness Chronic Disease Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

12 year–20 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Osher Center for Integrative Medicine

San Francisco, California, 94115, United States

About this study

The Communitas pilot study is a survey study of Communitas, a pre-existing integrative medicine and mind-body skills group visit for adolescents living with chronic illness and their parents. The goal of this study is to evaluate the preliminary efficacy and feasibility for these group visits. Approximately 50-100 patients and 50-100 parent enrollees of the Communitas group visits will be recruited to participate in this survey study optionally. During the group visits, both the patient and parent groups will learn about and experience various coping, self-care, pain and stress-reduction modalities, participate in group sharing to promote engagement with a diagnosis and provide emotional support, and benefit from facilitated discussions about some of the more practical aspects of living with chronic illness. The group visits will be offered to patients and their parents as clinical service, regardless of enrollment in the survey study, and will be billed to insurance as consult group visit with the pediatrician. The group visits will be held at both the Osher Center for Integrative Medicine and Mission Bay Children's Hospital and will be led by a pediatrician, starting in October 2016. The study will be set up as a pre-post evaluation, without a control group, using patient-report and parent-report qualitative and quantitative assessments at baseline, after completion of the series of group visits, and 3 months later. In addition, some families may be asked if they would like to participate in a videotaped interview before and after the start of the program.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Enrolled in the Communitas group visit at the UCSF Osher Center for Integrative Medicine or Mission Bay Children's Hospital.
  • Patients enrolled in these group visits are males and females 12-20 years of age and living with a chronic illness.

Exclusion criteria

  • People who are not enrolled in the Communitas group visit at the UCSF Osher Center for Integrative Medicine or Mission Bay Children's Hospital will be excluded from this survey study.
  • The Communitas group consists of a patient group of young people ages 12-20 living with chronic illness, as well as a parent group.

Treatment and study plan

Primary outcomes

  1. Physical wellbeing

    Time frame: Change from baseline NIH Promis Global Health instrument summary score at 2 months and at 5 months

    NIH Promis Global Health instrument summary score

  2. Mental wellbeing

    Time frame: Change from baseline NIH Promis Global Health instrument summary score at 2 months and at 5 months

    NIH Promis Global Health instrument summary score

  3. Perceived Stress

    Time frame: Change from baseline Perceived stress scale summary score at 2 months, and at 5 months

    Perceived stress scale summary score

  4. Mood: Tension

    Time frame: Change from baseline Profile of Mood States Tension instrument subscale score at 2 months and at 5 months

    Profile of Mood States Tension instrument subscale score

  5. Resilience

    Time frame: Change from baseline 14-Item Resilience Scale summary score at 2 months and at 5 months

    14-Item Resilience Scale summary score

  6. Social support

    Time frame: Change from baseline Social Support Scale summary score at 2 months, and at 5 months

    Social Support Scale summary score

  7. Mindfulness

    Time frame: Change from baseline Mindful Attention Awareness Scale summary score at 2 months, and at 5 months

    Mindful Attention Awareness Scale summary score

  8. Mood: Anger

    Time frame: Change from baseline Profile of Mood States Anger instrument sub scale score at 2 months, and at 5 months

    Profile of Mood States Anger instrument subscale score

  9. Mood: Depression

    Time frame: Change from baseline Profile of Mood States Depression instrument sub scale score at 2 months, and at 5 months

    Profile of Mood States Depression instrument subscale score

  10. Mood: Fatigue

    Time frame: Change from baseline Profile of Mood States Fatigue instrument sub scale score at 2 months, and at 5 months

    Profile of Mood States Fatigue instrument subscale score

Secondary outcomes

  1. Self-reported adherence, using Medical Outcomes Study General Adherence scale

    Time frame: Change from baseline Medical Outcomes Study General Adherence instrument summary score at 2 months, and at 5 months

    Medical Outcomes Study General Adherence instrument summary score

  2. pain medicine usage in past month

    Time frame: Change from baseline pain medicine usage in past month likert scale at 2 months, and at 5 months

    likert scale

  3. number visits to emergency department in past month

    Time frame: Change from baseline number visits to emergency department in past month at 2 months, and at 5 months

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Official study title

Effectiveness of a Mind-Body and Peer Support Program for Teens Living With Chronic Illness and Their Parents: A Pilot Study

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
May 30, 2017
Registry last updated
Sep 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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